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Quality Assurance Analyst – Fixed-Term Contract (until 31st December 2027)
About the Role
The Quality Assurance Analyst plays a key role in ensuring batch release activities are performed accurately and in compliance with regulatory requirements and internal quality standards. The role focuses on reviewing and coordinating batch documentation, supporting timely product release while maintaining high standards of data integrity and Good Manufacturing Practice (GMP).
Working cross-functionally with production, supply chain, quality control, and the Qualified Person (QP), the position directly contributes to the safe and efficient release of products.
Key Responsibilities
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Batch Document Review & Approval
- Prepare and review batch-specific documentation to ensure completeness and accuracy prior to Qualified Person (QP) certification, in alignment with EudraLex Volume 4, Annex 16.
- Perform additional batch review activities, including production checks and formulation sheet reviews.
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System Engagement & Process Compliance
- Execute quality-related tasks within systems like LIMS and SAP relevant to batch release processes.
- Support batch tracking activities and communicate quality-related issues to stakeholders in a timely manner.
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Project & Improvement Contributions
- Participate in projects and initiatives related to batch record review and process improvement.
- Manage archiving and handling of batch documentation, including in-process documentation control.
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Operational Quality Support
- Provide operational support in line with business needs, including:
- Supporting deviation management, investigations, and change control.
- Assisting with document control processes.
- Participating in internal audits and quality system maintenance.
- Provide operational support in line with business needs, including:
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Compliance Execution
- Ensure compliance with EU GMP, internal procedures, and applicable regulatory/biosafety requirements.
Requirements
Technical & Operational Experience
- Strong understanding of Good Manufacturing Practice (GMP) principles and data integrity requirements.
- Experience working in a regulated industry environment (e.g., pharmaceutical or biologics manufacturing) is advantageous.
- Familiarity with batch record review processes or similar quality assurance activities is preferred.
- Ability to work with quality and business systems (e.g., LIMS, SAP or equivalents).
Soft Skills & Competencies
- Strong attention to detail and ability to accurately review technical documentation.
- Well-developed organisational and prioritisation skills, with the capacity to manage multiple tasks in a dynamic environment.
- Effective communication skills (written and verbal), enabling collaboration across cross-functional teams and stakeholders.
- Proactive and solution-oriented mindset, with a collaborative problem-solving approach.
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Education & Certifications
- Basic proficiency in Microsoft Office tools (e.g., Excel, PowerPoint, Outlook).
- A degree or educational background in a scientific or related field would be advantageous.
Other Requirements
- A Disclosure and Barring Service (DBS) check will be required for the successful candidate.
- Any offer of employment will be subject to a satisfactory DBS certificate.
Why Join us?
Boehringer Ingelheim has been recognised as a Top Employer in the UK, reflecting our commitment to building an exceptional workplace through:
- Strong people practices
- Supportive HR policies
To explore why working at Boehringer Ingelheim (BI) is rewarding, visit: Boehringer Ingelheim Careers UK – Why Work Here.
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